A cardiac intervention suturing device with magnetic elements

Abstract

This application provides a cardiac interventional suturing device with a magnetic component. The device includes a puncture section, a suture section, a first fixation section, a retraction section, and a drive mechanism. After the puncture section is unfolded by controlling the suture section, the puncture section is controlled to move towards the magnetic component until it penetrates the tissue to be sutured and is attracted and fixed by the magnetic component. The drive mechanism controls the retraction section to retract the first fixation section, thereby retracting the puncture section. The suture is then sutured by tying a knot at the first and second ends of the suture section. Using the suturing device provided in this application, there is no residual implant in the patient's body, no inherent risk of diaphragmatic occlusion, no implant-induced embolism, and no risk of arrhythmia, etc.

Description

Technical Field

[0001] The embodiments of this application belong to the field of clinical surgical instruments, and more specifically, relate to a cardiac interventional suturing device with a magnetic component. Background Technology

[0002] Congenital heart disease refers to abnormalities in the physical structure or function of the heart or major blood vessels in the chest cavity caused by formation disorders or developmental abnormalities of the heart and major blood vessels during embryonic development, or by the failure of channels that should close automatically after birth to close. These include ventricular septal defects, atrial septal defects, patent foramen ovale, etc.

[0003] With the development of science and technology, these unclosed channels can now be closed through interventional surgical procedures.

[0004] Occluders have been used clinically for over twenty years and are very mature medical devices. However, because occluders are implanted foreign bodies in the human body, they pose risks of embolism and arrhythmia. Most importantly, patients need to take anticoagulants, and the use of metal occluders can obstruct important surgical pathways.

[0005] Even though biodegradable occluders have emerged to allow unobstructed surgical access, they are still implants that need to be degraded and metabolized within the patient's body, and may still pose a risk of embolism. Moreover, they are more expensive than ordinary metal occluders.

[0006] Therefore, surgical methods that reduce the risk of embolism, reduce the number of implants required by patients, and lower treatment costs are urgently needed in clinical practice. Summary of the Invention

[0007] To address the technical problems existing in the current occluders when sealing channels that have failed to close, this application provides a cardiac interventional suturing device with a magnetic component, comprising: a puncture part, a suturing part, a first fixing part, a retracting part, and a driving mechanism.

[0008] The first end of the folding part is connected to the first fixing part, and the second end of the folding part is connected to the driving mechanism;

[0009] The suture part is surrounded by a first tube, the first end of the suture part passes through the first fixing part and is connected to the puncture part, the second end of the suture part is connected to the second fixing part, the first fixing part is rotatably connected to the first end of the first tube, the first tube is surrounded by a second tube, the first end of the second tube is provided with a magnetic element, and the second ends of the first tube and the second end of the second tube are both connected to the driving mechanism.

[0010] A third tube is sleeved around the second tube. A gripping member is provided at the end of the third tube away from the first fixing part. The driving mechanism is provided on the gripping member. The puncture part, the first fixing part, the suture part and the gathering part extend or retract into the third tube under the drive of the driving mechanism.

[0011] After the puncture part is unfolded by controlling the suture part, the puncture part is moved toward the magnetic component until the puncture part penetrates the tissue near the site to be sutured and is attracted and fixed by the magnetic component. The first fixing part is then closed by controlling the folding part through the drive mechanism so that the first fixing part passes through the channel of the site to be sutured. The site to be sutured is then sutured through the first end and the second end of the suture part.

[0012] In a preferred embodiment of this application, the first tube includes a first tube body and a third fixing part, the first fixing part being rotatably connected to a first end of the first tube body or the third fixing part, and the second end of the first tube body being connected to a driving mechanism.

[0013] In a preferred embodiment of this application, the third fixing part is provided with a first through hole, and the suture part passes through the first through hole and connects with the puncture part.

[0014] In a preferred embodiment of this application, the first tube body and the puncture portion are located on the same side of the first fixing portion.

[0015] In a preferred embodiment of this application, a rotating member is provided on the first tube body or the third fixing part, and the first fixing part is connected to the rotating member.

[0016] In a preferred embodiment of this application, the first fixing part includes a plurality of spaced fixing members, each of which is provided with a second through hole and a third through hole. The tail of the piercing part is disposed in the second through hole, and the first end of the gathering part is fixed in the third through hole.

[0017] In a preferred embodiment of this application, the plurality of fasteners are distributed around the periphery of the first tube in both the retracted and extended states.

[0018] In a preferred embodiment of this application, the first fixing part includes four fixing members, which are spaced 90 degrees apart when in the unfolded state.

[0019] In a preferred embodiment of this application, the puncture portion includes a plurality of puncture elements, and the puncture elements are configured in a one-to-one correspondence with the fixing element.

[0020] In a preferred embodiment of this application, the puncture member includes a puncture member body and a tip that are connected to each other. The puncture member body is a hollow columnar structure, and the suture portion passes through the puncture member body and is connected to the tip.

[0021] In a preferred embodiment of this application, the gathering part includes a plurality of gathering components, the first end of the gathering component is connected to the first fixing part, and the second end of the gathering component is connected to the driving mechanism.

[0022] In a preferred embodiment of this application, a plurality of the described retracting members are spaced apart around the periphery of the first tube.

[0023] In a preferred embodiment of this application, the magnetic component is a hollow columnar structure, and the magnetic component is sleeved around the gathering part and the first tube.

[0024] In a preferred embodiment of this application, the suture portion includes a plurality of suture lines.

[0025] In a preferred embodiment of this application, the driving mechanism includes a first driving mechanism, a second driving mechanism, and a third driving mechanism. The first driving mechanism is connected to a first tube and is used to drive the first tube to move the puncture part toward or away from the magnetic component. The second driving mechanism is connected to the retracting part and is used to drive the retracting part to retract the first fixing part. The third driving mechanism is connected to the second tube and is used to drive the magnetic component to move toward or away from the puncture part through the movement of the second tube.

[0026] Compared with the prior art, the present application provides a cardiac interventional suturing device with a magnetic component. The device includes: a puncture part, a suture part, a first fixation part, a retracting part, and a driving mechanism. After the puncture part is unfolded by controlling the suture part, the puncture part is controlled to move towards the magnetic component until it penetrates the tissue near the site to be sutured and is attracted and fixed by the magnetic component. The driving mechanism controls the retracting part to retract the first fixation part so that the first fixation part passes through the channel of the site to be sutured. The site to be sutured is sutured through the first end and the second end of the suture part. By suturing the site to be sutured with the suturing device provided in this application, there is no residual implant in the patient's body, no inherent risk of diaphragmatic occlusion, no implant-induced embolism, and no risk of arrhythmia, etc. Attached Figure Description

[0027] The accompanying drawings, which are included to provide a further understanding of this application and form part of this application, illustrate exemplary embodiments and are used to explain this application, but do not constitute an undue limitation of this application. Some specific embodiments of this application will be described in detail below with reference to the accompanying drawings in an exemplary and non-limiting manner. The same reference numerals in the drawings designate the same or similar parts or components. Those skilled in the art should understand that these drawings are not necessarily drawn to scale. In the drawings:

[0028] Figure 1 This is a schematic diagram of the overall structure of the suturing device provided in the embodiments of this application;

[0029] Figure 2 This is a schematic diagram of the front end structure of the suture device provided in an embodiment of this application;

[0030] Figure 3 This is a schematic diagram illustrating the working principle of the suturing device provided in the embodiments of this application;

[0031] Figures 4 to 8 A diagram illustrating the changing states of the suture device during use, as provided in the embodiments of this application.

[0032] Figure 9 This is a schematic diagram of the seam on the room partition provided in an embodiment of this application. Detailed Implementation

[0033] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs; the terminology used herein in the specification of the application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application; the terms "comprising" and "having," and any variations thereof, in the specification, claims, and foregoing drawings of this application are intended to cover non-exclusive inclusion. The terms "first," "second," etc., in the specification, claims, or foregoing drawings of this application are used to distinguish different objects, not to describe a particular order.

[0034] To enable those skilled in the art to better understand the present application, the technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are merely some, not all, of the embodiments of the present application. All other embodiments obtained by those skilled in the art based on the embodiments of the present application without creative effort should fall within the scope of protection of the present application.

[0035] In the embodiments of this application, the site to be sutured can be the foramen ovale of the heart, atrial septal defect, structural channels caused by surgery, etc.

[0036] like Figure 1 As shown, the suturing device includes: a puncture part 101, a suturing part 102, a first fixing part 103, a gathering part 108, and a driving mechanism; the first end of the gathering part 108 is connected to the first fixing part 103, and the second end of the gathering part 108 is connected to the driving mechanism.

[0037] The suture portion 102 is surrounded by a first tube 109, and the suture portion 102 can move within the first tube 109. The first end of the suture portion 102 passes through the first fixing part 103 and is connected to the tail of the puncture part 101. The second end of the suture portion 102 is connected to a second fixing part (not shown), and the second end of the suture portion 102 can be fixed by the second fixing part (not shown). The first fixing part 103 is rotatably connected to the first end of the first tube 109. The first tube 109 is surrounded by a second tube 105, and the first end of the second tube 105 is provided with a magnetic element 104. The second ends of the first tube 109 and the second end of the second tube 105 are both connected to the driving mechanism. In this embodiment, the suture portion 102 includes a plurality of sutures, which are made of biodegradable materials or metal, and the plurality of sutures pass through the first tube 109.

[0038] A third tube 106 is sleeved around the second tube 105. A gripping member 107 is provided at the end of the third tube 106 away from the first fixing part 103. The driving mechanism is provided on the gripping member 107. The gripping member 107 is used by the operator to operate the gripping part of the suture device. The driving mechanism is provided on the gripping member 107 as an operation button. The puncture part 101, the first fixing part 103, the suture part 102, and the gathering part 108 extend or retract into the third tube 106 under the drive of the driving mechanism.

[0039] After the operator controls the suture section 102 to pull and unfold the puncture section 101, the puncture section 101 is controlled to move towards the magnetic component 104 until the puncture section 101 penetrates the tissue and is attracted and fixed by the magnetic component 104. During the process of the puncture section 101 penetrating the tissue, in order to facilitate better contact between the puncture section 101 and the magnetic component 104, the second tube 105 is driven by the drive mechanism to move towards the puncture section 101 so that the puncture section 101 can be attracted and fixed by the magnetic force of the magnetic component 104. The puncture section 101 is made of metal. The first fixing part 103 is retracted by the retracting part 108 controlled by the drive mechanism so that the first fixing part 103 passes through the channel of the part to be sutured. Then, the first tube 109 is controlled by the drive mechanism to move towards the holding part 107 until the first fixing part 103 passes through the channel of the part to be sutured. The suture device is then removed from the body. The operator completes the suture action by suturing through the first and second ends of the suture section 102.

[0040] In this embodiment, the driving mechanism can be a single driving mechanism or different driving mechanisms. In this embodiment, the driving mechanism includes a first driving mechanism 107-2, a second driving mechanism 107-3, and a third driving mechanism 107-1. The first driving mechanism 107-2 is connected to the first tube 109 and is used to drive the first tube 109 to move the puncture part 101 toward or away from the magnetic component 104. The second driving mechanism 107-3 is connected to the gathering part 108 and is used to drive the gathering part 108 to gather the first fixing part 103. The third driving mechanism 107-1 is connected to the second tube 105 and is used to move the magnetic component 104 toward or away from the puncture part 101 through the movement of the second tube 105.

[0041] like Figure 2 As shown, the first tube 109 includes a first tube body 109-1 and a third fixing part 109-2. The first fixing part 103 is rotatably connected to the first end of the first tube body 109-1 or the third fixing part 109-2. The second end of the first tube body 109-1 is connected to the first driving mechanism 107-2.

[0042] In order to enable the first fixing part 103 to be rotatably connected to the first end of the first tube body 109-1 or the third fixing part 109-2, a rotating member 109-3 is provided on the first tube body 109-1 or the third fixing part 109-2. The first fixing part 103 is connected to the rotating member 109-3. The rotating member 109-3 is a columnar structure that can rotate with the movement of the first fixing part 103. The rotating member 109-3 is located at the part where the first fixing part 103 contacts the first tube 109. That is to say, the first fixing part 103 can rotate around the rotating member 109-3.

[0043] The third fixing part 109-2 is provided with a first through hole (not shown), and the suture part 102 passes through the first through hole (not shown) and is connected to the puncture part 101. In this embodiment of the application, in order to better realize the puncture process of the puncture part 101, the first tube body 109-1 and the puncture part 101 are distributed on the same side of the first fixing part 103.

[0044] The first fixing part 103 includes a plurality of spaced fixing members 103-1. Each fixing member 103-1 is provided with a second through hole 103-2 and a third through hole 103-3. The tail of the piercing part 101 is disposed in the second through hole 103-2, and the first end of the retracting part 108 is fixed in the third through hole 103-3. The setting of the third fixing part 109-2 can better realize the unfolding of the fixing members 103-1 in the first fixing part 103 at a preset angle. In this embodiment, there are four fixing members 103-1. When the four fixing members 103-1 are unfolded, they are spaced 90 degrees apart. In this embodiment, because there are a plurality of fixing members 103-1, a rotating member 109-3 corresponding to the number of fixing members 103-1 is provided on the side of the third fixing part 109-2 facing the first tube 109. This makes it easier to realize that the fixing members 103-1 rotate with the drive of the retracting part 108.

[0045] When the first fixing part 103 is closed, in order to ensure that the force is evenly distributed around the first fixing part 103, the multiple fixing members 103-1 are distributed around the first tube 109 in both the unfolded and closed states, and the multiple fixing members 103-1 are spaced apart. This makes it convenient for the puncture part 101 connected to the first fixing part 103 to be evenly distributed to penetrate the tissue near the site to be sutured.

[0046] In this embodiment of the application, the puncture part 101 includes a plurality of puncture elements, each of which is correspondingly arranged with the fixation element 103-1. As a preferred embodiment of the application, there are four fixation elements 103-1, and therefore four puncture elements. The tail of the puncture element is connected to the suture part 102, and when the first fixation part 103 is unfolded, the fixation element 103-1 is arranged perpendicularly to the first tube 109.

[0047] The puncture component includes a puncture component body 101-2 and a tip 101-1 connected to each other. The puncture component body 101-2 is a hollow columnar structure. The suture portion 102 passes through the puncture component body 101-2 and is connected to the tip 101-1. The tip 101-1 is made of metal.

[0048] The gathering part 108 includes a plurality of gathering components. The first end of each gathering component is connected to the first fixing part 103, and the second end of each gathering component is connected to the second driving mechanism 107-3. When the first fixing part 103 is gathered, in order to achieve uniform force around the first fixing part 103, the plurality of gathering components are spaced apart around the first tube body 109-1. As another embodiment of this application, the gathering part 108 can also be disposed inside the first tube body 109-1. This application does not limit this.

[0049] In order to enable the magnetic component 104 to be sleeved around the first tube body 109-1 and the gathering part 108, the magnetic component 104 is a hollow columnar structure.

[0050] like Figure 3 As shown, during the foramen ovale closure, when the guidewire 110 and sheath 111 are deployed from the right atrium 112 to the left atrium 113, the guidewire 110 is removed, and the foramen ovale closure device is delivered along the sheath 111 to the foramen ovale 114 and then to the left atrium 113. The third tube 106 is then withdrawn to the right atrium 112 via the gripper 107, so that the puncture part 101 and the first fixation part 103 of the front end are located in the left atrium 113, and the rest are located in the right atrium 112.

[0051] The following describes in detail the suturing process of the foramen ovale of the heart using a cardiac interventional suturing device with magnetic components provided in the embodiments of this application.

[0052] like Figure 4 As shown, during foramen ovale closure, guidewire 110 and sheath 111 are delivered to foramen ovale 114. When guidewire 110 and sheath 111 are deployed from right atrium 112 to left atrium 113, guidewire 110 is removed. Then, the suturing device is delivered along sheath 111 to foramen ovale 114 and reaches left atrium 113. The third tube 106 is withdrawn to right atrium 112 so that puncture part 101 and first fixation part 103 are in left atrium 113, and the rest is in right atrium 112. At this time, puncture part 101 is in a retracted state.

[0053] like Figure 5 As shown, the operator controls the suture part 102 to pull the first fixation part 103 to unfold the puncture part 101 so that the puncture part 101 moves toward the magnetic component 104 to perform the puncture action. Then, the operator controls the first drive mechanism 107-2 to drive the puncture part 101 to move toward the magnetic component 104 to perform the puncture process, that is, the puncture part 101 punctures the secondary septum 115 and the primary septum 116.

[0054] like Figure 6 As shown, after the puncture part 101 penetrates the secondary septum 115 and primary septum 116 of the tissue near the site to be sutured, the puncture part 101 is attracted and fixed by the magnetic element 104, and at the same time, the first tube 109 is driven by the driving mechanism to move away from the driving mechanism until the puncture part 101 is separated from the first fixing part 103.

[0055] like Figure 7 As shown, the multiple fasteners 103-1 are gathered together by the gathering part 108 so that the first fastener 103 passes through the foramen ovale 114 to the right atrium 112.

[0056] like Figure 8 The first tube 109 is driven by the drive mechanism to move closer to the drive mechanism until the first fixing part 103 passes through the foramen ovale 114 to the right atrium 112. The third tube 106 is driven by the gripper 107 to move along the axial direction to wrap around the puncture part 101 and the third fixing part 109-1. Then the suture device is retracted into the sheath 111 and withdrawn from the body. At this time, as Figure 9 As shown, there will be sutures 117 on the secondary septum 115 and the primary septum 116. The sutures 117 are tied in pairs to complete the process of suturing the oval foramen 114.

[0057] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of this application, and are not intended to limit them. Although this application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features therein. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of this application.

Claims

1. A cardiac intervention suturing device with magnetic elements, characterized in that, include: Puncture section, suture section, first fixing section, gathering section and drive mechanism; The first end of the folding part is connected to the first fixing part, and the second end of the folding part is connected to the driving mechanism; The suture part is surrounded by a first tube, the first end of the suture part passes through the first fixing part and is connected to the puncture part, the second end of the suture part is connected to the second fixing part, the first fixing part is rotatably connected to the first end of the first tube, the first tube is surrounded by a second tube, the first end of the second tube is provided with a magnetic element, and the second ends of the first tube and the second end of the second tube are both connected to the driving mechanism. A third tube is sleeved around the second tube. A gripping member is provided at the end of the third tube away from the first fixing part. The driving mechanism is provided on the gripping member. The puncture part, the first fixing part, the suture part and the gathering part extend or retract into the third tube under the drive of the driving mechanism. After the puncture part is unfolded by the suture part, the puncture part is moved toward the magnetic component until the puncture part penetrates the tissue near the suture site and is attracted and fixed by the magnetic component. The first fixing part is closed by the drive mechanism so that the first fixing part passes through the suture site channel. The suture site is sutured by the first end and the second end of the suture part. The first fixing part includes a plurality of fixing members distributed at intervals. Each fixing member is provided with a second through hole and a third through hole. The tail of the piercing part is disposed in the second through hole, and the first end of the gathering part is fixed in the third through hole. The multiple fasteners are distributed around the periphery of the first tube when in the retracted or unfolded state; The puncture section includes multiple puncture components, and each puncture component is provided in a one-to-one correspondence with the fixation component.

2. A cardiac access suturing device with magnetic elements as defined in claim 1, characterized in that, The first tube includes a first tube body and a third fixing part. The first fixing part is rotatably connected to a first end of the first tube body or the third fixing part, and the second end of the first tube body is connected to a driving mechanism.

3. A cardiac intervention suturing device with magnetic elements as in claim 2, wherein, The third fixing part is provided with a first through hole, and the suture part passes through the first through hole and connects to the puncture part.

4. A cardiac interventional suturing device with a magnetic component as described in claim 2, characterized in that, The first tube body and the puncture portion are located on the same side of the first fixing portion.

5. A cardiac intervention suturing device with magnetic elements as claimed in claim 2, wherein, A rotating component is provided on the first tube body or the third fixing part, and the first fixing part is connected to the rotating component.

6. The cardiac interventional suturing device with a magnetic component as described in claim 1, characterized in that, The first fixing part includes four fixing members, which are spaced 90 degrees apart when in the unfolded state.

7. A cardiac intervention suturing device with magnetic elements as in claim 1, wherein, The puncture device includes a puncture device body and a tip that are connected to each other. The puncture device body is a hollow columnar structure, and the suture portion passes through the puncture device body and is connected to the tip.

8. A cardiac intervention suturing device with magnetic elements as in claim 1, wherein, The gathering part includes multiple gathering components, the first end of which is connected to the first fixing part, and the second end of which is connected to the driving mechanism.

9. A cardiac intervention suturing device with magnetic elements as in claim 8, wherein, Multiple of the aforementioned retractable components are spaced apart around the periphery of the first tube.

10. A cardiac intervention suturing device with magnetic elements as in claim 1, wherein, The magnetic component is a hollow columnar structure, and it is sleeved around the gathering part and the first tube.

11. The cardiac interventional suturing device with a magnetic element as described in any one of claims 1 to 5, 7 to 10, characterized in that, The suture section includes multiple suture lines.

12. A cardiac intervention suturing device with magnetic elements as in claim 11, wherein, The driving mechanism includes a first driving mechanism, a second driving mechanism, and a third driving mechanism. The first driving mechanism is connected to a first tube and is used to drive the first tube to move the puncture part toward or away from the magnetic component. The second driving mechanism is connected to the retracting part and is used to drive the retracting part to retract the first fixing part. The third driving mechanism is connected to the second tube and is used to drive the magnetic component to move toward or away from the puncture part through the movement of the second tube.

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